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New updates in insulin products, as well as non-pharma therapies are on the horizon for diabetes.
Diabetes medications were the most expensive traditional therapy drugs in 2016, with an overall trend of 19.4%, according to the latest Express Scripts drug trend report. This positive trend is reflective of increases in both utilization and cost.
Here’s how pipeline developments could change the landscape.
“While I do not see any game-changing medications within the diabetes class that will reach the market within the next several years, there are a few updates that we are watching,” says Chris Peterson, director in the emerging therapeutics department at Express Scripts.
He points to the continued growth of the sodium-dependent glucose cotransporter-2 (SGLT-2) inhibitor class-sparked by the positive cardiovascular outcomes from empagliflozin (Jardiance, Boehringer Ingelheim/Eli Lilly), a previously approved SGLT2 inhibitor. Pipeline SGLT-2 inhibitors include investigational ertugliflozin (Merck and Pfizer) and bexagliflozin (Chugai Pharma), both in phase 3 development at press time. Sotagliflozin (Lexicon Pharmaceuticals), a first-in-class oral dual SGLT-1 and SGLT-2 inhibitor for type 1 and type 2 diabetes, also in phase 3. If approved, it will be the first oral drug approved for type 1 diabetes, a disease that typically has been managed by lifestyle modifications and insulins, says Farrah Wong, PharmD, director, pipeline and drug surveillance at OptumRx.
The glucagon-like peptide-1 (GLP-1) analog class is also expected to grow, says Peterson. This is driven by cardiovascular outcomes data with liraglutide (Victoza, Novo Nordisk) and the introduction of the fixed-dose combination GLP-1 agonist/long-acting insulin products, insulin glargine and lixisenatide injection (Soliqua 100/3, Sanofi) and insulin degludec/liraglutide (Xultophy, Novo Nordisk).
Semaglutide is a GLP-1 agonist in development for glycemic control in patients with type 2 diabetes. It is being developed as both subcutaneous formulation from Novo Nordisk and oral form from Novartis. If approved, it will be the first oral GLP-1 agonist on the market.
“As oral drugs are easier to administer and less invasive than injectable drugs, oral semaglutide may offer these advantages over other GLP-1 agonists,” says Wong. “Furthermore, type 2 diabetics will have another oral therapeutic option in a class of drugs that thus far were only injectable drugs.”
Exenatide osmotic mini-pump (ITCA 650, Intarcia Therapeutics, Inc.) is a subcutaneous implant that continuously delivers the GLP-1 agonist, exenatide, for three months (introductory dose) or six months (maintenance dose) to treat type 2 diabetes. Approval is expected in November 2017, says Peterson.
New insulin products are also expected to receive approval soon, including insulin tregopil (Biocon Ltd.), an oral insulin in phase 2 development for type 1 and type 2 diabetes.
“Currently, insulins are either injected or inhaled,” says Wong. “If an oral insulin product is available, the ease of administration may drive some of the market share to shift from injectable/inhaled insulins to the oral product.”
Insulin glargine injection (Basaglar, Eli Lilly/Boehringer Ingelheim) approved last year, was the first “follow-on” insulin glargine product to treat diabetes. Another “follow-on” insulin glargine product, known as MK-1293 (Merck/Samsung Bioepis), will be competing as a brand product within the market and is expected to be approved in the second quarter of 2017. Basalog is yet another insulin glargine product currently in phase 3 development; however, it is not yet clear whether the manufacturer, Mylan, will seek approval as a competing brand or as a generic to Lantus (Sanofi). Finally, Sanofi is developing SAR342434, a follow-on protein to Lilly's Humalog (insulin lispro), for the treatment of diabetes mellitus. If approved, it will compete as a brand with the other rapid-acting insulins.
Continued development of non-pharmacologic treatments is expected. Three key areas to watch, according to Kim White, vice president, Numerof & Associates, Inc., include:
· Artificial pancreas technology,
· Islet cell transplantation, and
· Medical management technology.
Artificial pancreas technology continuously monitors blood glucose levels and adjusts insulin doses automatically. According to White, an artificial pancreas device from Medtronic was approved last fall and Bigfoot Biomedical and Insulet Corporation are currently working on similar technology.
Islet cell transplantation is being studied for type 1 diabetes, says White. According to the American Diabetes Association, islets are clusters of cells in the pancreas that make insulin. Islet cell transplantation is a procedure in which islets from the pancreas of a deceased organ donor are purified, processed, and transferred to another person.
“Although first identified as a way to treat people with type 1 diabetes in the 1960s, islet cell transplantation has been difficult to develop as a viable treatment for type 1 diabetes, which is due largely to the challenges of collecting enough islet cells to transplant and preventing transplant rejection,” says White. “However, last year an NIH [National Institutes of Health]-funded study was completed that will pave the way for manufacturing of purified human pancreatic islet cells.”
Mobile technology has been a growing area of interest for diabetes management, says White. Although many blood glucose monitor manufacturers already have web-based programs and apps available to support diabetes management, there is ongoing research by numerous companies to better connect physicians and patients to patients’ blood glucose levels and other measurements like blood pressure.
Peterson says these new products will add more competitors to the already existing therapy classes, helping to mitigate the increasing trend within the diabetes class.
He explains that the trend in the diabetes therapy class is just one example of why it is critical for payers to manage their benefit. Express Scripts has developed several initiatives to address the affordability and accessibility of diabetes treatments including a new partnership with Eli Lilly and Blink Health that will provide a 40% discount on Eli Lilly insulin products for uninsured patients with diabetes.
Express Scripts also recently launched a diabetes remote monitoring solution to improve outcomes and address the 42.8% of people with diabetes who are nonadherent to therapy. By using a connected glucose meter and ongoing monitoring from their Diabetes Therapeutic Resource Center, patients learn how to control their blood sugar levels, according to Express Scripts.
“The challenge facing managed healthcare executives is striking the right balance between providing the necessary support to prevent, treat and manage the disease with ensuring the patient is compliant and adheres to physician guidance,” says White. “The current developments [in the pipeline] have the potential to dramatically improve patient outcomes by minimizing individual errors caused by missed or inappropriate medication dosing and developing accountability loops with providers.”
Erin Bastick, PharmD, RPh, is a staff pharmacist at Southwest General Health Center in Middleburg Heights, Ohio.